The EPA's Deadly Delaying Tactics

In a bizarre new testing program, Al Gore and the EPA want to use animal tests to guess how much of a toxin children should be able to tolerate. Called the Voluntary Children's Chemical Evaluation Program (VCCEP; originally called the Child Health Testing Program), if a chemical dose doesn't kill rats or make them sick, the EPA says it's fine for your children to swallow it, too.

Let's assume that chemicals don't belong in foods, air, water, and breast milk. Keep zero tolerance—or background levels—as our guide. Using animal tests to set supposedly "safe" levels of toxic exposures for kids makes no sense.

The Physician's Committee for Responsible Medicine has worked tirelessly to stop the EPA's deadly Voluntary Children's Chemical Evalutation Program by researching and compiling a comprehensive report, organizing a press conference, placing controversial billboard ads, and distributing leaflets to publicize the wastefulness of this program, among other efforts. Physician's Committee for Responsible Medicine has the support of many organizations and individuals, including actor Edward Asner.

For a brief summary, click here for Physician's Committee for Responsible Medicine president Neal Barnard, M.D.'s letter to Ward Penberthy of the EPA, which outlines Physician's Committee for Responsible Medicine's position and alternative proposal to the EPA's VCCEP.

Review commonly asked questions and answers about the EPA's program and Physician's Committee for Responsible Medicine's alternative plan.

Please write to Vice President Gore at The White House, Washington, DC 20500. Ask him to stop endless testing and start cleaning up our kids' environment. Click here for Physician's Committee for Responsible Medicine's resolution and its supporting organizations.

Distribute Physician's Committee for Responsible Medicine's leaflet page 1 & page 2 and educate the public about the EPA's deadly Voluntary Children's Chemical Evaluation Program.

Learn more about the EPA's program and Physician's Committee for Responsible Medicine's alternative proposal presented in our comprehensive report.

Keep apprised of Physician's Committee for Responsible Medicine's efforts to halt this wasteful program.

LETTER FROM PCRM PRESIDENT NEAL D. BARNARD, M.D. TO THE EPA'S WARD PENBERTHY

Ward Penberthy, EPA
Chemical Control Division (7405)
Office of Pollution Prevention and Toxics
Environmental Protection Agency
401 M St., S.W.
Washington, DC 20460

This letter addresses the Straw Proposal for the Voluntary Children's Health Chemical Testing Program (VCHCTP) issued on November 16,1999.

We remain concerned that the EPA's approach to the issue of the potential danger of industrial chemicals in our environment rests on the use of animal tests to establish "acceptable" exposure levels. This is inappropriate for a number of reasons, including the following:

Major differences exist between humans and rodents in their tolerance of and reaction to chemicals. Differences in absorption, distribution, biotransformation, and excretion may render a chemical harmless in one species, but highly toxic in another. Faith in animal tests to accurately reflect human toxicity contradicts years of observations in toxicology illustrating unexpected differences. As noted toxicologist Dennis Parke wrote in the Polish Journal of Occupational Medicine:

Or as Karl Rozman noted in Toxicologic Pathology: "It is well recognized that species differences impose considerable limitations on our ability to predict the toxicity of a compound from one species to another." (Rozman 1988)

Further discussion of these species differences are provided by: Lewis 1998, Green 1990, Ruelius 1987, Smith 1991, Eason 1990, McLean 1979, and Nau 1986.

We are surprised that EPA toxicologists have neglected to even touch on this serious problem of interpretation, as it renders data elicited in the program essentially useless.

The proposed tests do not account for intraspecies differences. Within the human population, some individuals will be much more sensitive to certain types of toxicity than others. Animals in laboratory tests typically show much less genetic diversity than human beings. Toxiciologist David Lewis recently noted, "Laboratory-bred rodent species such as the rat and mouse tend to be genetically pure strains and therefore are unlikely to be subject to the considerable interindividual variation in p450 complement that is apparent in human ethnographic populations." (Lewis 1998) The number of animals used in laboratory experiments cannot accurately reflect the heterogeneity of the human population nor represent the most sensitive individuals. What this means is that, not only will rodent tests tell us little about reactions in humans, the reactivity within the human population to certain chemicals may be sufficiently varied as to render judgments even more difficult. As toxicologist A.E.M McClean observed in the Proceedings of the Royal Society of London: "The crude and mechanical description of, say, lethal effects in one species will tell us little about other species, or about variation inside a species." (McLean 1979).

For further discussion of intraspecies diversity see: Dybing 1999, Miller 1999a, and Miller 1999b.

None of this means that it is impossible to take effective steps to protect humans. It does, however, mean that we must favor a zero-tolerance (or as close to zero tolerance as possible) approach. Animal tests are no substitute.

As David Carpenter of the Department of Environmental Health and Toxicology, School of Public Health, University at Albany, noted, "Unlike laboratory animals, people are rarely exposed to a single hazardous chemical." (Carpenter 1998) Chemical combinations are typically additive, but may exhibit antagonism, synergism, or independent effects.

For further discussion, see: Shulka 1984, Taylor 1995, and Gardner HS Jr 1998.

For cases of additive or synergistic toxicity, exposure to a combination of chemicals at levels below the observed threshold for toxicity can produce a net toxic result. Additionally, animal tests cannot be used to assess the nearly endless possible combinations of chemical exposure to predict synergistic effects. The only sensible approach is reduction of chemical exposures to zero wherever possible.

In addition to these major concerns, we also take issue with specific points of the Straw Proposal as follows:

Point 3 under the section "Rationale for Key Program Design Features" on page 2 again ignores the problems in interspecies extrapolation. It states: "Hazard data being sought by this program are relevant to an understanding of the inherent toxicological properties of a specific chemical and can be useful in assessing the risks associated with a variety of exposure scenarios. Exposure data, on the other hand, do not represent inherent properties of a chemical and have site- or use-specific relevance."

The data from any individual toxicity test do not represent an inherent property of the chemical. As noted above, toxicity data have species-specific relevance, and a wide range of toxicity is to be expected in a large population of genetically diverse subjects, e.g., humans. Additionally, the toxicity of a chemical is dependent on the combination of chemicals to which an individual is exposed.

5. Critical Need for More Exposure Assessment, Not Rodent Toxicology Programs

Point 6 on page 3 states: "Generally, EPA believes it would be more protective to use exposure arguments to trigger dropping chemicals rather than to use exposure data to trigger additional testing."

In the absence of sufficient exposure data, the EPA is calling for more hazard data. A more sensible approach would be an expansion of programs providing the needed exposure data. Ironically, critical exposure monitoring programs such as NHEXAS remain in limbo. Currently, the EPA is conducting a cost-benefit analysis to determine the future of NHEXAS. The Integrated Human Exposure Committee found the program to be "an excellent project that has significant promise for improving health in a cost effective manner" and "found NHEXAS to be outstanding in design and implementation." However the committee was "concerned about the limited resources allocated to the analysis of the NHEXAS data and the lack of strategic follow-up studies."

The pilot studies assessed exposure only in three study regions. The chemical exposures assessed were limited to a small number of chemicals already identified as potentially hazardous, including volatile organic compounds, pesticides, metals, and polyaromatic hydrocarbons. NHEXAS should be expanded both in terms of geographic range of study and the number of chemicals studied and assessed.

Likewise, the number of chemicals requiring reporting for inclusion in the Toxic Release Inventory (TRI) should be greatly increased. Currently, mandatory reporting and public disclosure through the TRI is required for only 579 individually listed chemicals and 28 chemical categories. Failure to extend the required TRI reporting to a much wider selection of chemicals violates the public's "right to know."

Under "Test Battery," on page 7, the document states: "EPA has heard little from stakeholders indicating that other specific studies included in the test battery presented to SAP are inappropriate."

PCRM has consistently pointed out that animal tests for toxicity, including acute, chronic, neurotoxicity, immunotoxicity, developmental toxicity, carcinogenicity, and reproductive and fertility effects, are unreliable indicators of the potential for toxicity in humans. The literature cited earlier indicates serious doubts within the toxicological community of the reliability of animal tests for predicting human toxicity.

The developmental neurotoxicity test has been roundly criticized, and the problems with this test will not be reiterated here. The two-year rodent bioassay is also well known for its failure to accurately predict human risk. Indeed, mouse and rat tests diverge fully 30 percent of the time, and extrapolation to humans would be even more tenuous. As one review of these dramatic differences notes, "It is painfully clear that carcinogenesis in the mouse cannot now be predicted from positive bioassay data obtained in the rat and vice versa." (Di Carlo 1984)

Tests for teratogenicity have been cited as being little more than a public relations exercise. The failure of animal tests to identify human teratogens is well known. (Nau 1986, Stern 1981)

As for the focus on industrial chemicals, the Vice President's1998 press release states that "EPA will identify chemicals that children are disproportionately exposed to and consider whether additional health effects testing is needed."

We therefore take issue with the dismissal, in the Straw Proposal, of our concerns with lead poisoning, fetal alcohol syndrome, heterocyclic amines, tobacco smoke, etc. There is little doubt that these chemical dangers exert a greater toll than any of the chemicals slated for testing in the EPA's proposed program.

We would like to remind those working on this program that, in proposing that the EPA consider the broad range of threats to children, we have the support of the National Coalition Against the Misuse of Pesticides, Northwest Coalition for Alternatives to Pesticides, National Organization on Fetal Alcohol Syndrome, Association of Birth Defect Children, National Coalition of the Chemically Injured, Action on Smoking and Health, Child Health Foundation, Mothers & Others for a Livable Planet, and Earth Island Institute.

We are troubled that the EPA, and those to whom the EPA is responsible, have dismissed this proposal out of hand. The key part of the public's "right to know" is what deleterious chemicals or other substances are in their food, water, air, or body tissues, and what they can do to reduce these exposures. Increased monitoring of chemical exposure, as well as voluntary and regulatory action to reduce exposure wherever possible is the only sensible way to protect children. Let me ask you please to use the guidelines of the enclosed program to address the threats children face.

References
Carpenter DO, Arcano KF, Bush B, Niemi WD, Pang S, Vakharia DD. Human health and chemical mixtures: an overview. Environ Health Perspect 1998;106(Suppl 6):1263-70.
Di Carlo FJ. Carcinogenesis bioassay data: correlation by species and sex. Drug Metab Rev 1984;15(3):409-13.
Dybing E, Soderlund EJ. Situations with enhanced chemical risks due to toxicokinetic and toxicodynamic factors. Regul Toxicol Pharmacol 1999;30(2 Pt 2):S27-30.
Eason CT, Bonner FW, Parke DV. The importance of pharmacokinetic and receptor studies in drug safety evaluation. Regulatory Toxicology and Pharmacology 1990;11:288-307
Gardner HS Jr, Brennan LM, Toissaint MW, Rosencrance AB, Boncavage-Hennesey EM, Wolfe MJ. Environmental complex mixture toxicity testing. Environ Health Perspect 1998;106(Suppl 6):1299-305.
Lewis DFV, Ioannides C, Parke DV. Cytochromes 450 and species differences in xenobiotic metabolism and activation of carcinogen. Environ Health Perspect 1998;106(10):633-41.
McLean AEM. Hazards from chemicals: scientific questions and conflicts of interest. Proc R Soc Lond 1979;205:179-97.
Miller CS. Are we on the threshold of a new theory of disease? Toxicant-induced loss of tolerance and its relationship to addiction and abdiction. Toxicol Ind Health 1999a;15(3-4):284-94.
Miller CS. Exacerbation of chemical sensitivity: a case study. Toxicol Ind Health 1999b;15(3-4):398-402.
Nau H. Species differences in pharmacokinetics and drug teratogenesis. Environ Health Perspect 1986;70:113-29.
Parke DV, Ioannides C, Lewis DFV, Obrebska-Parke MJ. Current problems in the evaluation of chemical safety. Pol J Occup Med 1990;3(1):15-41.
Rozman K. Disposition of xenobiotics: species differences. Toxicol Pathol 1988;16(2):123-9.
Ruelius HW. Extrapolation from animals to man: predictions, pitfalls and perspectives. Xenobiotica 1987;17(3):255-265.
Shulka GS, Singhal RL. The present status of biological effects of metals in the environment: lead, cadmium, and manganese. Can J Physiol Pharmacol 1984;62:1015-31.
Smith DA. Species differences in metabolism and pharmacokinetics: are we close to an understanding? Drug Metabolism Reviews 1991;23(3&4):355-73.
Stern L. In vivo assessment of the teratogenic potential of drugs in humans. Obstet Gynecol 1981;58(5 Suppl):3S-8S.
U.S. Environmental Protection Agency. An SAB Advisory: The Integrated Human Exposure Committee of the Scientific Advisory Board. National Human Exposure Assessment Survey (NHEXAS) Pilot Studies. EPA-SAB-IHEC-ADV-99-004.
Taylor MS, Setzer RW, DeMarini DM. Examination of the additivity assumption using the spiral and standard Salmonella assays to evaluate binary combinations of mutagens. Mutation Research 1995;335:1-14.

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